Depression - Major Depressive DisorderMENTINANCT06919133
The Effect of Digital Markers in the Self-management of Depressive Symptoms
A study testing The MENTINA app in people with Depression - Major Depressive Disorder and Mental Distress, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 3 sites in 3 countries.
Trial summary
The purpose of the MENTINA trial is to investigate the effect of using the smartphone-based MENTINA app for self-monitoring of depressive symptoms and rule-based feedback in individuals with current or previous depression, psychological vulnerability, and increased risk of depression in a randomized controlled trial… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression - Major Depressive Disorder, Mental Distress
- What is being tested?
- The MENTINA app
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 660 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 13 May 2025to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Depressive symptoms, assessed by PHQ-9 > 8, AND/OR
- Current or previous depressive episode(s) (ICD-10 F32, F33)
- Owns and uses a smartphone
- Signed informed consent to participate
Who cannot join
- ICD-10 diagnosis of dementia, schizophrenia, mania, or bipolar disorder, as well as ongoing substance abuse
- Current psychotic depression
- Current suicide risk
- Acute somatic illness requiring treatment (intensive care)
- Insufficient language skills in Danish, German or Spanish and english (depending on site)
Trial locations and contacts
3 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 3 countries
About this study
Official title: The Effect of Digital Markers in the Self-management of Depressive Symptoms - The MENTINA Randomized Controlled Parallel Group Trial
The purpose of the MENTINA trial is to investigate the effect of using the smartphone-based MENTINA app for self-monitoring of depressive symptoms and rule-based feedback in individuals with current or previous depression, psychological vulnerability, and increased risk of depression in a randomized controlled trial (RCT) over a 12-month trial period. The aim is to potentially offer the MENTINA app as a self-management tool for individuals with psychological vulnerability and/or depressive symptoms or episodes.
Method and Design:
Read more
International, multicenter (three centers), parallel-group, RCT. The active group is assigned the smartphone-based MENTINA app including rule-based data feedback. The control group uses the MENTINA app for questionnaire-based data collection (outcomes) and collection of sensor-based data.
Study Procedures:
The trial will be open-label and unblinded. The trial uses the self-reported Patient Health Questionnaire-9 score (PHQ-9) as the primary outcome measure. Scoring will take place every 14 days over the 12-month trial period. Depressive symptoms during the first 6 months of app use will also be evaluated as secondary outcomes.
Participants, Including Inclusion and Exclusion Criteria A total of 220 individuals will be included from each center (Denmark, Germany, and Spain) with psychological vulnerability (depressive symptoms and possibly previous depressive episodes). A total sample size of 660 participants will be included.
Inclusion criteria:
- Age 18 years or older
- Depressive symptoms, assessed by PHQ-9 > 8, AND/OR
- Current or previous depressive episode(s) (ICD-10 F32, F33)
- Owns and uses a smartphone
- Signed informed consent to participate
Exclusion criteria:
- ICD-10 diagnosis of dementia, schizophrenia, mania, or bipolar disorder, as well as ongoing substance abuse
- Current psychotic depression
- Current suicide risk
- Acute somatic illness requiring treatment (intensive care)
- Insufficient language skills in Danish, German or Spanish (depending on site)
Side Effects, Risks, and Disadvantages
Side effects and risks:
We do not expect any serious side effects from using the MENTINA app. Possible side effects could include increased focus on one's own illness, potentially worsening depressive symptoms and suicidal thoughts.
Recruitment of Participants The study population will consist of adults vulnerable to mental health issues, defined by a PHQ-9 score > 8 or previous depressive symptoms at the time of inclusion. Each study site will be responsible for local recruitment and follow-up.
Read the detailed description
The intervention in the MENTINA trial consist of a smartphone app, which allows for daily monitoirng of symptoms such as mood, sleep, activity etc. Also, a library with content concerning depressive symptoms will be available.
Rules for feedback based of self-reported measures will be developed. Based on the self-reported measures participants will be suggested to read items from the library or call emergency health care facilities.
- Being tested
- The MENTINA app, Control
- Keywords
- Depression, Mental distress, Smartphone, Trial, self-management
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The MENTINA appDevice
A smartphone-based app is developed and used in this trial. The smartphone-based MENTINA app allows for daily self-monitoring of depressive symptoms such as mood, sleep, activity etc and rule-based feedback based on self-monitored data as well as collected sensor data. Libary with relevant content will also be available and incoorporated in the rule-based feedback.
ControlOther
The MENTINA app is installed but no content and self-monitoring is available. No rule-based feedback. Only outcome measures can be done.
| Study group | Role | What they receive |
|---|---|---|
| Smartphone-based self-monitoring and rule-based feedback | Experimental | The smartphone-based MENTINA app for daily self-monitoring of depressive symptoms and other symptoms + rule-based feedback based on self-monitoried data and sensor data from smartphones Receives: Device: The MENTINA app |
| Control | Placebo comparator | The app is installed for outcome measures, but no access to the content of the app is provided. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire 9 items (PHQ-9)
Differences between the intervention group and the control group in the total Patient Health Questionnaire 9 items (PHQ-9) score performed every 14th day during the 12-months trial period.
Measured: From enrollment and during the study period of 12 months
Secondary outcomes (7)
Quality of Life
Differences between the intervention group and the control group in the level of quality of life according to the WHO Quality of life BREF16 (WHO QoL)
Measured: From enrollmetn to end of treatment af 12 months
Generalized Anxiety Disorder 7 items scale (GAD-7)
Differences between the intervention group and the control group in the level of anxiety symptoms according to the Generalized Anxiety Disorder scale (GAD-7)
Measured: From enrollment to end of treatment at 12 months
PHQ-9
- Monthly change in PHQ-9 scores
- Response rate defined as the proportion of participants with ≥50% reduction in PHQ-9
- Remission rate defined as PHQ-9 ≤9 and ≥5-point improvement
- PHQ-9 scores at 6 months
- Area Under the Curve (AUC) for PHQ-9 over the trial period
- Subgroup analysis: differences between the two groups in PHQ-9 analyzed separately for:
- People with mental distress (without lifetime depression)
- People with a lifetime diagnosis of depression
Measured: From baseline and during the 12 months study period
Perceived Stress Scale (PSS)
Differences between the group
Measured: From baseline and during the 12 months study period
User-reported healthcare contacts
Number of healthcare contact during the study
Measured: From baseline and during the 12 months study period
Negative effects: Negative Effects Questionnaire (NEQ)
Differences between the two groups
Measured: Form baseline and during the 12 months study period
PHQ-9
- Number of depressive episodes (based on PHQ-9)
- Duration
- Number of depression-free days (based on PHQ-9)
Measured: From baseline and during the 12 months study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start13 May 2025
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depression - Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 660 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital del Mar Research Institute (IMIM), Research Centre of the German Foundation for Depression and Suicide Prevention, Monsenso, Monsenso A/S as sponsor
- Responsible party
- Principal investigator, Lars Vedel Kessing, Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06919133
- Sponsor's protocol ID
- 101080651
- Acronym
- MENTINA
- Status last verified
- Jan 2026
- First submitted
- 2 Apr 2025
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sensitive data that cannot be anonymised completely.
Publications
Faurholt-Jepsen M, Dyreholt MS, Kyster NB, Iversen N, Kortsen EM, Amann BL, Hogg B, Gatto D, Cordoba C, Petrovic M, Allenhof C, Schnitzspahn K, Reich H, Budtz-Jorgensen E, Kessing LV, Hegerl U. Effect of digital intervention in the self-management of depressive symptoms: the MENTINA trial - a study protocol for a randomised controlled parallel-group trial. BMJ Open. 2026 Feb 4;16(2):e115773. doi: 10.1136/bmjopen-2025-115773.
PubMed 41638726
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Digital Markers in the Self-management of Depressive Symptoms - The MENTINA Randomized Controlled Parallel Group Trial
- ClinicalTrials.gov ID
- NCT06919133
- Acronym / sponsor ID
- MENTINA / 101080651
- Keywords
- Depression, Mental distress, Smartphone, Trial, self-management
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 660 participants (estimated)
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg HospitalUniversity, hospital or other
- Collaborators
- Hospital del Mar Research Institute (IMIM), Research Centre of the German Foundation for Depression and Suicide Prevention, Monsenso, Monsenso A/S as sponsor
- Study start
- 13 May 2025 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 9 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the MENTINA trial is to investigate the effect of using the smartphone-based MENTINA app for self-monitoring of depressive symptoms and rule-based feedback in individuals with current or previous depression, psychological vulnerability, and increased risk of depression in a randomized controlled trial (RCT) over a 12-month trial period. The aim is to potentially offer the MENTINA app as a self-management tool for individuals with psychological vulnerability and/or depressive symptoms or episodes.
Method and Design:
International, multicenter (three centers), parallel-group, RCT. The active group is assigned the smartphone-based MENTINA app including rule-based data feedback. The control group uses the MENTINA app for questionnaire-based data collection (outcomes) and collection of sensor-based data.
Study Procedures:
The trial will be open-label and unblinded. The trial uses the self-reported Patient Health Questionnaire-9 score (PHQ-9) as the primary outcome measure. Scoring will take place every 14 days over the 12-month trial period. Depressive symptoms during the first 6 months of app use will also be evaluated as secondary outcomes.
Participants, Including Inclusion and Exclusion Criteria A total of 220 individuals will be included from each center (Denmark, Germany, and Spain) with psychological vulnerability (depressive symptoms and possibly previous depressive episodes). A total sample size of 660 participants will be included.
Inclusion criteria:
- Age 18 years or older
- Depressive symptoms, assessed by PHQ-9 > 8, AND/OR
- Current or previous depressive episode(s) (ICD-10 F32, F33)
- Owns and uses a smartphone
- Signed informed consent to participate
Exclusion criteria:
- ICD-10 diagnosis of dementia, schizophrenia, mania, or bipolar disorder, as well as ongoing substance abuse
- Current psychotic depression
- Current suicide risk
- Acute somatic illness requiring treatment (intensive care)
- Insufficient language skills in Danish, German or Spanish (depending on site)
Side Effects, Risks, and Disadvantages
Side effects and risks:
We do not expect any serious side effects from using the MENTINA app. Possible side effects could include increased focus on one's own illness, potentially worsening depressive symptoms and suicidal thoughts.
Recruitment of Participants The study population will consist of adults vulnerable to mental health issues, defined by a PHQ-9 score > 8 or previous depressive symptoms at the time of inclusion. Each study site will be responsible for local recruitment and follow-up.
Detailed description
The intervention in the MENTINA trial consist of a smartphone app, which allows for daily monitoirng of symptoms such as mood, sleep, activity etc. Also, a library with content concerning depressive symptoms will be available.
Rules for feedback based of self-reported measures will be developed. Based on the self-reported measures participants will be suggested to read items from the library or call emergency health care facilities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smartphone-based self-monitoring and rule-based feedback | Experimental | Device: The MENTINA appThe smartphone-based MENTINA app for daily self-monitoring of depressive symptoms and other symptoms + rule-based feedback based on self-monitoried data and sensor data from smartphones |
| Control | Placebo comparator | Other: ControlThe app is installed for outcome measures, but no access to the content of the app is provided. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years or older
- Depressive symptoms, assessed by PHQ-9 > 8, AND/OR
- Current or previous depressive episode(s) (ICD-10 F32, F33)
- Owns and uses a smartphone
- Signed informed consent to participate
Key exclusion criteria (5 listed)
- ICD-10 diagnosis of dementia, schizophrenia, mania, or bipolar disorder, as well as ongoing substance abuse
- Current psychotic depression
- Current suicide risk
- Acute somatic illness requiring treatment (intensive care)
- Insufficient language skills in Danish, German or Spanish and english (depending on site)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The MENTINA appA smartphone-based app is developed and used in this trial. The smartphone-based MENTINA app allows for daily self-monitoring of depressive symptoms such as mood, sleep, activity etc and rule-based feedback based on self-monitored data as well as collected sensor data. Libary with relevant content will also be available and incoorporated in the rule-based feedback. | Device | Smartphone-based self-monitoring and rule-based feedback |
| ControlThe MENTINA app is installed but no content and self-monitoring is available. No rule-based feedback. Only outcome measures can be done. | Other | Control |
Primary outcome
Patient Health Questionnaire 9 items (PHQ-9)
Time frame: From enrollment and during the study period of 12 months
Differences between the intervention group and the control group in the total Patient Health Questionnaire 9 items (PHQ-9) score performed every 14th day during the 12-months trial period.
7 secondary outcomes
Quality of Life
Time frame: From enrollmetn to end of treatment af 12 months
Generalized Anxiety Disorder 7 items scale (GAD-7)
Time frame: From enrollment to end of treatment at 12 months
PHQ-9
Time frame: From baseline and during the 12 months study period
Perceived Stress Scale (PSS)
Time frame: From baseline and during the 12 months study period
User-reported healthcare contacts
Time frame: From baseline and during the 12 months study period
Negative effects: Negative Effects Questionnaire (NEQ)
Time frame: Form baseline and during the 12 months study period
PHQ-9
Time frame: From baseline and during the 12 months study period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Derived from this study: PubMed 41638726Faurholt-Jepsen M, Dyreholt MS, Kyster NB, Iversen N, Kortsen EM, Amann BL, Hogg B, Gatto D, Cordoba C, Petrovic M, Allenhof C, Schnitzspahn K, Reich H, Budtz-Jorgensen E, Kessing LV, Hegerl U. Effect of digital intervention in the self-management of depressive symptoms: the MENTINA trial - a study protocol for a randomised controlled parallel-group trial. BMJ Open. 2026 Feb 4;16(2):e115773. doi: 10.1136/bmjopen-2025-115773.
- Individual participant dataSharing planned: No. Sensitive data that cannot be anonymised completely.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The MENTINA app in people with Depression - Major Depressive Disorder and Mental Distress, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark, Germany, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire 9 items (PHQ-9) (time frame: From enrollment and during the study period of 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06919133, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.